Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075955
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/18/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/075955s015lbl.pdf
06/30/2010 SUPPL-12 Labeling

Label is not available on this site.

09/12/2007 SUPPL-9 Labeling

Label is not available on this site.

06/27/2006 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/075955s015lbl.pdf

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 076232 AKORN
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 204550 AUROBINDO PHARMA LTD
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 075761 FRESENIUS KABI USA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077161 GLAND PHARMA LTD
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077234 HIKMA FARMACEUTICA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 075955 HOSPIRA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 203884 HOSPIRA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 203885 HOSPIRA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 076217 MYLAN INSTITUTIONAL
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077610 WOCKHARDT
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077834 WOCKHARDT
NEXTERONE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 022325 BAXTER HLTHCARE

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